510(k) Report

FDA applicant

Prevent Products, Inc.

W St Paul, MN3 decisions1994–20010 recalls

FDA records 3 decisions for Prevent Products, Inc. (W St Paul, MN) from 1994 to 2001: 3 510(k) clearances. Most are in product codes BXB (Exerciser, Powered) and JOW (Sleeve, Limb, Compressible). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Prevent Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Prevent Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Prevent Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BXBExerciser, Powered2decisions
  • JOWSleeve, Limb, Compressible1decision

What has FDA decided for it lately?

  • K003284Phlebopump, Model 1000Prevent Products, Inc. · 2001
  • K952975Ankle Calf Exerciser PhlebopumpPrevent Products, Inc. · 1996
  • K942618Ankle Calf ExerciserPrevent Products, Inc. · 1994

All 3 as Prevent Products, Inc. →